- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03203174
The Use of Microneedles With Topical Botulinum Toxin for Treatment of Palmar Hyperhidrosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Split-hand Microneedle group: After the subject has been consented, the Treatment Visit will commence. Subjects will be randomized into one of two groups. Binary randomization for microneedle pretreatment of the right vs. the left hand (Dominant hand has higher strength which may skew side effect reporting of weakness).
The evaluation of sweat production will be done using the subjective patient reported Hyperhidrosis Disease Severity Scale (HDSS) and objective gravimetric measurement. Hyperhidrosis Disease Severity Scale (HDSS) is a scale from 1 to 4. Values of 1 or 2 represent Mild/moderate disease, and 3 or 4 represent severe disease. Successful treatment is indicated by improvement from 3 or 4 to 1 or 2. One point improvement in HDSS score is associated with 50% reduction in sweat production and a two-point improvement with an 80% reduction, according to the Canadian Hyperhidrosis Advisory Committee.
Gravimetric measurement includes collecting sweat secretion on standardized filter. Prior to any measurements, the subject will be asked to sit in a climate-controlled room for 15 min to allow for acclimatization. Filter paper is first weighed on a high-precision laboratory scale. The filter papers are then placed in the subject's palms for 5 minutes, and weighed again. This technique has already been used in other studies of hyperhidrosis [5]. The difference in the weight (g) will allow calculation of sweat secretion in grams per 5 minutes.
The subject's palm will be cleansed with gauze. Then the microneedle pretreatment versus sham microneedle pretreatment will be performed. This will consist of rolling the microneedles or sham microneedles into the skin for several seconds on the sides of the palm that have respectively been randomized to the microneedle or control treatment. Sham microneedles will consist of a flat roller without the presence of the microneedles. The microneedles are solid and are long enough to penetrate the stratum corneum and enter the epidermis. Microneedles that are less than 700 micrometers in length have been shown to induce minimal pain, and our ongoing work with microneedles that were 650 micrometers in length was rated a 1 out of 10 on a visual analog pain scale. For this study, subjects will rate pain on a visual analog scale after the microneedle pretreatment as well.
Next a Transepidermal Water Loss Meter (Tewameter) will be used to measure the water evaporation gradient on the skin. Measurements will be performed with non-invasive devices that have been widely used for the study of skin barrier function. Each device has a flat-top electrode (approximate diameter of 1cm) that will come in contact with the skin surface during measurements. This device does not deliver any energy into the skin. The subjects will not experience discomfort during and after the measurements. The electrode tip will be cleaned with alcohol wipes between subjects.
Next, the subject will asked to grade their discomfort with the pretreatment step on a 10 cm visual analog pain scale.
Next, botulinum toxin A solution will be mixed per standard protocol in the dermatology clinic and will be applied and evenly spread over the palm. This will be followed by occlusion with an occlusive wrap such as saran wrap or a silicone based gel. The subject will be asked to keep the saran wrap in place for 1 hour. Botulinum toxin A is an FDA approved product for the treatment of hyperhidrosis.
Follow-up visits will be at 4-6 weeks post treatment. During the follow-up visit the patient will be asked about side effects or any adverse events. Also a repeat evaluation of sweat production will be done using the subjective patient reported Hyperhidrosis Disease Severity Scale (HDSS) and objective gravimetric measurement. They will also complete a global satisfaction survey.
Split-hand Botulinum Toxin A group: After the subject has been consented, the Treatment Visit will commence. Subjects will be randomized into one of two groups. Binary randomization for botulinum toxin A of the right vs. the left hand (Dominant hand has higher strength which may skew side effect reporting of weakness).
The evaluation of sweat production will be done using the subjective patient reported Hyperhidrosis Disease Severity Scale (HDSS) and objective gravimetric measurement. Hyperhidrosis Disease Severity Scale (HDSS) is a scale from 1 to 4. Values of 1 or 2 represent Mild/moderate disease, and 3 or 4 represent severe disease. Successful treatment is indicated by improvement from 3 or 4 to 1 or 2. One point improvement in HDSS score is associated with 50% reduction in sweat production and a two-point improvement with an 80% reduction, according to the Canadian Hyperhidrosis Advisory Committee.
Gravimetric measurement includes collecting sweat secretion on standardized filter. Prior to any measurements, the subject will be asked to sit in a climate-controlled room for 15 min to allow for acclimatization. Filter paper is first weighed on a high-precision laboratory scale. The filter papers are then placed in the subject's palms for 5 minutes, and weighed again. This technique has already been used in other studies of hyperhidrosis [5]. The difference in the weight (g) will allow calculation of sweat secretion in grams per 5 minutes.
The subject's palm will be cleansed with gauze. Then the microneedle pretreatment will be performed on both palms. This will consist of rolling the microneedles into the skin for several seconds on the sides of the palm. The microneedles are solid and are long enough to penetrate the stratum corneum and enter the epidermis. Microneedles that are less than 700 micrometers in length have been shown to induce minimal pain, and our ongoing work with microneedles that were 650 micrometers in length was rated a 1 out of 10 on a visual analog pain scale (results of IRB# 282150). For this study, subjects will rate pain on a visual analog scale after the microneedle pretreatment as well.
Next a VapoMeter will be used to measure the water evaporation gradient on the skin. The Vapometer measures the transepidermal water loss (TEWL) and evaporation rates. Measurements will be performed with non-invasive devices that have been widely used for the study of skin barrier function (Figure 1) [6]. Each device has a flat-top chamber (approximate diameter of 1cm) that will come in contact with the skin surface during measurements. This device has a humidity sensor and does not deliver any energy into the skin. The subjects will not experience discomfort during and after the measurements. The electrode tip will be cleaned with alcohol wipes between subjects.
Next, the subject will asked to grade their discomfort with the pretreatment step on a 10 cm visual analog pain scale.
Next, botulinum toxin A solution will be mixed per standard protocol in the dermatology clinic and will be applied and evenly spread over the palm that was randomized for treatment with botulinum toxin A. The other palm will be treated with a placebo (saline). This will be followed by occlusion with an occlusive wrap such as saran wrap, a silicone based gel, or glove. The subject will be asked to keep the saran wrap, silicone gel, or glove in place for 1 hour. Botulinum toxin A is an FDA approved product for the treatment of hyperhidrosis.
Follow-up visits will be at 4-6 weeks post treatment. During the follow-up visit the patient will be asked about side effects or any adverse events. Also a repeat evaluation of sweat production will be done using the subjective patient reported Hyperhidrosis Disease Severity Scale (HDSS) and objective gravimetric measurement. They will also complete a global satisfaction survey.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Sacramento, California, United States, 95816
- UC Davis Department of Dermatology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 12 years of age and older (split-hand microneedle group only)
- 18 years of age and older (split-hand botulinum toxin A group)
- Subjects with palmar hyperhidrosis
- Do not meet any of the exclusion criteria
Exclusion Criteria:
- Subjects who smoke
- Subjects who have established allergy to topical botulinum toxin
- Subjects with a personal or family history of neuromuscular disorder
- Subjects who have had botulinum toxin to the hands in the past 6 months
- Subjects who have had other systemic anticholinergic therapy in the past 2 weeks
- Subjects with known thyroid related disorders or systemic infection.
- Subjects who are pregnant or who plan to become pregnant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Split-hand Microneedle Botulinum Toxin A
One palm with microneedle pretreatment prior to application of topical botulinum toxin A
|
Microneedles are small needles used to create holes in the stratum corneum (top layer of skin) with relatively low amount of pain.
Botulinum toxin type A will be applied to the palm
Saline applied to the palm
|
Sham Comparator: Split-hand Sham Microneedle Botulinum Toxin A
Contralateral palm with sham microneedle pretreatment prior to application of topical botulinum toxin A
|
Botulinum toxin type A will be applied to the palm
Saline applied to the palm
Flat roller with no needles on the roller
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
subjective patient reported Hyperhidrosis Disease Severity Scale (HDSS)
Time Frame: 1 month follow up
|
a scale from 1 to 4. Values of 1 or 2 represent Mild/moderate disease, and 3 or 4 represent severe disease.
|
1 month follow up
|
objective gravimetric measurement
Time Frame: 1 month follow up
|
collecting sweat secretion on standardized filter, difference in the weight (g) will allow calculation of sweat secretion in grams per 5 minutes
|
1 month follow up
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Sivamani RK, Stoeber B, Liepmann D, Maibach HI. Microneedle penetration and injection past the stratum corneum in humans. J Dermatolog Treat. 2009;20(3):156-9. doi: 10.1080/09546630802512679.
- Sivamani RK, Liepmann D, Maibach HI. Microneedles and transdermal applications. Expert Opin Drug Deliv. 2007 Jan;4(1):19-25. doi: 10.1517/17425247.4.1.19.
- Sivamani RK, Stoeber B, Wu GC, Zhai H, Liepmann D, Maibach H. Clinical microneedle injection of methyl nicotinate: stratum corneum penetration. Skin Res Technol. 2005 May;11(2):152-6. doi: 10.1111/j.1600-0846.2005.00107.x.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Sweat Gland Diseases
- Skin Diseases
- Hyperhidrosis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- 561309
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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